Evaluation of the effect of oral metronidazole and cefixime as prophylaxis in uncomplicated appendicitis in comparison with ceftriaxone and metronidazole injection
Evaluation of the effect of oral metronidazole and cefixime as prophylaxis in uncomplicated appendicitis in comparison with ceftriaxone and metronidazole injection
Design
Clinical trial with control group with mosaic group, randomized. Phase 2-3, on 200 patients with acute appendicitis,no blinding. Used for randomization by random block method
Settings and conduct
This clinical trial study is performed in Imam Hossein Hospital in Tehran. Patients with a diagnosis of acute appendicitis are included in the study. In the intervention group, metronidosal 500 mg with cefixime 400 mg orally and in the control group 500 mg metronidzval with 1 g of injectable ceftriaxone.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Patients are who were operated with clinical diagnosis of appendicitis's.
Exclusion criteria: Patients with complicated appendicitis (perforated and peritonitis,The underlying diseases (diabetes mellitus, acquired or intrinsic Immunodeficiency)Iimmunosuppressive drugs,Inability to follow patient
Intervention groups
Intervention group: Metronidazole 500 mg with cefixime 400 mg orally.
Control group:Metronidazole 500 mg and one gram of ceftriaxone both injectable
Main outcome variables
Purulent discharge of the wound,Pain at the wound site,warmth in the woundذ postoperatively compared in both groups.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160523028008N12
Registration date:2021-02-25, 1399/12/07
Registration timing:prospective
Last update:2021-02-25, 1399/12/07
Update count:0
Registration date
2021-02-25, 1399/12/07
Registrant information
Name
Mohammad Faryadras
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3428 9706
Email address
m.faryadras@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-20, 1400/01/31
Expected recruitment end date
2021-06-21, 1400/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of oral metronidazole and cefixime as prophylaxis in uncomplicated appendicitis in comparison with ceftriaxone and metronidazole injection
Public title
The effect of antibiotics on reducing infection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients are who were operated with clinical diagnosis of appendicitis's.
Exclusion criteria:
Patients with complicated appendicitis (perforated and peritonitis
The underlying diseases (diabetes mellitus, acquired or intrinsic Immunodeficiency)
immunosuppressive drugs
inability to follow patients
Age
From 10 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all four sheets are drawn. The four paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of School of Medicine - Shahid Beheshti University of Medical Sciences
Street address
Faculty of Medicine, Shahid Beheshti University of Medical Sciences, Arabi St., Yaman St., Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2021-01-26, 1399/11/07
Ethics committee reference number
IR.SBMU.MSP.REC.1399.654
Health conditions studied
1
Description of health condition studied
Acute appendicitis
ICD-10 code
K35
ICD-10 code description
Acute appendicitis
Primary outcomes
1
Description
Purulent discharge of the wound
Timepoint
3,7 days, one month and three months after surgery
Method of measurement
Visual secretion
2
Description
Pain at the wound site
Timepoint
3,7 days, one month and three months after surgery
Method of measurement
asking the patient
3
Description
warmth in the wound
Timepoint
3,7 days, one month and three months after surgery
Method of measurement
Visual examination of the patient
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Metronidazole 500 mg with cefixime 400 mg orally
Category
Prevention
2
Description
Control group:Metronidazole 500 mg and one gram of ceftriaxone both injectable
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hussein Hospital
Full name of responsible person
Khosro Ayazi
Street address
Imam Hussein Hospital, Madani St, Nezam-Abad
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2387 1000
Email
kh-ayazi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Shahid Beheshti University of Medical Sciences, Arabi St., Yaman St., Chamran Highway
City
Theran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2387 1000
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Behbahan University of Medical Sciences
Full name of responsible person
Khosro Ayazi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Imam Hussein Hospital, Madani St, Nezam-Abad
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2387 1000
Email
kh-ayazi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Behbahan University of Medical Sciences
Full name of responsible person
Khosro Ayazi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Imam Hussein Hospital, Madani St, Nezam-Abad
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2387 1000
Email
kh-ayazi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Khosro Ayazi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Imam Hussein Hospital, Madani St, Nezam-Abad
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2387 1000
Fax
Email
kh-ayazi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD